Orthinox 6364-2-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153122005), received between Jun 12, 2019 and Apr 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PAIN. A STEM (IMPLANTED (B)(4) 2012), HEAD AND LINER (BOTH IMPLANTED (B)(4) 2014) WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, AND ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 04-APRIL-2023: PER OFFICE NOTES RECEIVED DATED (B)(6) 2022: PATIENT IS EXHIBITING "AREAS OF POSTERIOR PROXIMAL FEMORAL OSTEOLYSIS BETWEEN THE MID AND UPPER FEMORAL CEMENT MANTLE" AND AN "IMPINGEMENT PIT OR CYSTIFICATION ALSO NOTED IN THE SUPEROLATERAL ASPECT OF [THE] FEMORAL NECK." ADDITIONALLY, "THE RECENT CAT SCAN SHOWS DRAMATICALLY SIGNIFICANT CORTICAL BONE LOSS OR OSTEOLYSIS DEVELOPING AROUND THE FEMORAL CEMENT MANTLE" AND THE "CORTEX IS BECOMING REMARKABLY THIN IN SOME REGIONS." UPDATE 14-APRIL-2023: THE OFFICE NOTES ALSO ALLEGED "UNDERLYING SOFT TISSUE DAMAGE FROM METALLOSIS".

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 16782257 ↗
• InjuryJun 12, 2019Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF EXETER TOTAL HIP REPLACEMENT. UPDATE 05/JUNE/2019 WG: AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT PRESENTED TO SURGEON WITH PAIN IN RIGHT HIP. RTHR PREVIOUS 5 YEARS". ADDITIONAL DETAILS PROVIDED BY REP: "DURING THE REVISION OPERATION THE REASON WAS EVIDENT WITH METALOSIS. FROM MY OBSERVATION THE FEMORAL HEAD WAS SITTING LOOSELY ON THE FEMORAL COMPONENT". UPDATE: "I BELIEVE THAT TRUNIONOSIS WAS NOTED IN THE PERI OPERATIVE STAGE."

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8691370 ↗